Sperm Preparation Techniques for Infertility
(PIoUS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Disqualifiers: Significant disease, Psychiatric disorder, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial compares two ways of preparing sperm for fertility treatment. One method spins the sperm to pick out the good ones, while the other uses a special device to sort them naturally. The study aims to see which method leads to better pregnancy outcomes for patients undergoing intrauterine insemination.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Density gradient centrifugation, Density Gradient Centrifugation, Isopycnic Centrifugation, Rate-Zonal Centrifugation, Zymot Multi sperm separation device, ZyMōt Multi Sperm Separation Device, ZyMōt ICSI Sperm Separation Device for infertility?
Research shows that density gradient centrifugation can improve sperm quality by increasing motility and reducing damage, which is important for successful fertilization. Additionally, the ZyMot Multi device has been shown to improve clinical pregnancy rates in IVF by selecting sperm with better DNA integrity.
12345Is sperm preparation using techniques like density gradient centrifugation and ZyMōt devices safe for humans?
The available research suggests that sperm preparation techniques like density gradient centrifugation and ZyMōt devices are generally safe for use in humans, as they are commonly used in assisted reproductive technologies like in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) without reported safety concerns.
23467How does the treatment using Density Gradient Centrifugation and ZyMōt Multi Sperm Separation Device differ from other infertility treatments?
The Density Gradient Centrifugation and ZyMōt Multi Sperm Separation Device are unique because they focus on selecting the best quality sperm by separating them based on their density and motility, which can improve the chances of successful fertilization. Unlike some other methods, the ZyMōt device uses microfluidic technology to gently select sperm without the stress of centrifugation, potentially preserving sperm quality better.
13489Eligibility Criteria
This trial is for individuals assigned female at birth, under the age of 41, who are undergoing intrauterine insemination due to anovulation or unexplained infertility. It's not suitable for those with significant diseases or psychiatric disorders that affect consent, users of frozen donor sperm, non-English speakers, or those with prior intrauterine inseminations.Inclusion Criteria
Patients who are getting intrauterine insemination.
I am a woman under 41 years old.
Exclusion Criteria
I am using frozen donor sperm for conception.
Non-English speaker
You have had a previous intrauterine insemination.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo intrauterine insemination treatment with either density gradient centrifugation or Zymot sperm separation device over three cycles
3 months
Multiple visits as per treatment cycle
Follow-up
Participants are monitored for pregnancy outcomes until referred for prenatal care at 8-10 weeks of pregnancy
5 months
Participant Groups
The study compares two methods of preparing sperm before intrauterine insemination: Zymot Multi (a microfluidic sorting device) and density gradient centrifugation. The goal is to see which method leads to better pregnancy outcomes in a randomized controlled setting.
2Treatment groups
Active Control
Group I: Density gradient centrifugationActive Control1 Intervention
Patients will undergo sperm preparation by density gradient centrifugation
Group II: Zymot sperm separation deviceActive Control1 Intervention
Patients will undergo sperm preparation by the Zymot sperm separation device
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCSF Center for Reproductive HealthSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
References
Comparing the clinical outcomes of intrauterine insemination by two different density gradient preparation methods. [2019]Sperm preparation has play an integral part in the success of in-vitro fertilization. The aim of this study was to compare 2 different density gradient preparations for sperm separation in respect to sperm recovery, motility, motion parameters and clinical outcome after intrauterine insemination.
Sperm selection of cryopreserved milt of catfish (Rhamdia quelen) by density gradient centrifugation with AllGrad® 90. [2021]Density gradient centrifugation is a technique used to wash or separate samples of cryopreserved milt, mainly in humans and bovines allowing, for example, reducing the concentration of cryoprotectants or choosing the best portion of sperm. The proposed method seeks to reduce the presence of cryoprotectant in the cryopreserved milt of the Rhamdia qhelen and to obtain a fraction of better quality sperm. Gradient centrifugation was formed from 90% AllGrad® and different centrifugation times and forces were compared. The separated sperm presented a low increase in motility and decreased head damage and presence of gout, however, it was better compared to the non-separated samples. The speed of 1000 × g for 10 min, 4 °C, allowed 22.25 ± 4.64% of normal spermatozoa, that is, 9.25% more than the non-centrifuged milt (p = 0.0013).•The centrifugation method allows a fraction of spermatozoa morphologically less affected by cryopreservation.•Density gradient centrifugation with AllGrad® 90% is proposed as a tool of easy adaptation and application for the separation of cryopreserved sperm of R. quelen.•Density gradient centrifugation method at 1000 × g for 10 min allows obtaining a better fraction of normal sperm.
Comparing the Multi-ZSC one-step standardized swim-up method to the double-wash swim-up method with regard to the effects of sperm separation on morphology, head morphometry, and acrosome reaction inducibility. [2019]The objective of this study was to test the efficacy of the new Multi-ZSC system on human sperm separation compared with the commonly used double-wash swim-up method. It was found that the double-wash swim-up method selects sperm with better head morphometry and acrosome reaction inducibility than the upper fractions of the Multi-ZSC.
Selection of frozen-thawed stallion semen by microfluidic technology. [2023]The use of microfluidic technology is increasing in artificial reproduction technologies: With a small amount of semen, it allows for the selection of sperm with the best characteristics of kinetics, morphology and chromatin integrity. The ZyMot Multi (850 μl) is the most popular device of ZyMot Fertility Inc. To date, it was proven to be a valid instrument for sperm selection for in vitro fertilization and intracytoplasmic sperm injection in men. The aim of this study was to test the efficacy of the ZyMot Multi (850 μl) for stallion semen. Frozen-thawed semen from 15 stallions that were previously classified as being of 'good fertility' (GF; n = 8; pregnancy rate ≥ 40%) and 'poor fertility' (PF; n = 7; pregnancy rate
Comparative Study of Sperm Selection Techniques for Pregnancy Rates in an Unselected IVF-ICSI Population. [2023](1) Background: Semen analysis is a poor predictor of the fertilization potential of spermatozoa and a male factor may contribute to poor outcomes of the IVF procedure, despite a normal semen analysis. The microfluidic sperm selection (ZyMot-ICSI) is based on the selection of the spermatozoa with the lowest DNA fragmentation rate, but studies do not prove better clinical outcomes after this method. (2) Methods: We conducted a retrospective trial comparing 119 couples that were allocated to the classic gradient centrifugation sperm method (control group), and 120 couples that were allocated with the microfluidic technique being used (study group) at our university-level clinic, to go through IVF. (3) Results: The statistical analysis showed that there is no significant difference between the fertilization rate (study vs. control p = 0.87), but regarding blastocyst rate (study vs. control p = 0.046) and clinical pregnancy (p = 0.049), there is quite a significant statistical difference. Microfluidic preparation of spermatozoa seems to improve the results and it may be utilized more broadly for ICSI, and could also improve the workflow in standard IVF, decrease intervention by laboratory personnel and provide more consistent incubation conditions. (4) Conclusions: The patients that had the sperm preparation for ICSI with the microfluidic sperm selection had slightly better results compared with the gradient centrifugation selection.
[Separation of spermatozoa using Percoll gradients: value for in vitro fertilization]. [2006]Male infertility can be successfully treated by In Vitro Fertilization (IVF) and Embryo Transfer. However in case of oligo asthenospermia it is often difficult to select enough spermatozoa with good motility for the oocytes insemination. To cope with this problem, in 27 IVF cycles, sperm selection was performed by centrifugation on discontinuous Percoll density gradient. This method was demonstrated to be more efficient than swim-up migration to select motile sperm. The cleavage rate (63%) and the pregnancy rate per cycle (22%) were both satisfying. Centrifugation on discontinuous Percoll gradient was also found to be highly efficient for the removal of bacterial contaminants from semen (20 IVF cycles); the cleavage rate (66%) and the pregnancy rate per cycle (35%) were also quite satisfying. It can be concluded that centrifugation on discontinuous Percoll gradient is a useful method for sperm preparation in IVF in case of oligo-asthenospermia and in case of bacterial contamination in semen.
Outcome of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) using human sperm prepared via a new standardized swim-up technique fit for office use. [2020]Objective: Recent developments in the assisted reproductive technology (ART) areas necessitate the use of new and more efficient and acceptable modes of gamete in vitro manipulation techniques. As established via the use of various forms of ART, the natural process of fertilization has been largely bypassed and the gametes are obtained and manipulated outside of the normal means of conception. For the male, improvements in sperm quality have involved the use of various techniques that aim to recover a small percentage of healthy spermatozoa that can be further used for the different ART procedures. Previous IVF results showed no differences in fertilization rates between ZSC and Percoll recovered sperm (Zarmakoupis-Zavos et al. ACOG, 1997). The current study was designed to study the fertilizing capacity of ZSC recovered spermatozoa and subsequent embryonic development and pregnancy rates established via IVF and ICSI procedures.Methods: Sperm specimens (n = 30) were prepared via the use of the standardized ZSC swim-up technique, which was designed to harvest almost all overlayered media at the end of the procedure to maximize the sperm recovery. The ZSC device consists of a column with a conical cavity where the semen is placed, and from where the sperm swim-up into the overlayered media and are subsequently recovered at the end of the procedure. Semen specimens were initially assessed and then prepared (0.5 mL each) via the ZSC swim-up technique. The enhancement of the routine semen parameters was assessed and the recovered specimens were used for either conventional IVF or ICSI.Results: The results of the fertilization and pregnancy via IVF and ICSI are shown below:The generated results point out that ZSC recovered specimens yielded acceptable levels of fertilization and pregnancy rates in our IVF and ICSI program. Furthermore, the IVF inseminations yielded higher fertilization rates with a slight increase in polyspermic oocytes when compared to the ICSI inseminations.Conclusion: The data generated in this study tend to point out that the ZSC, besides being a simple one-step standardized system, can also be effectively employed in an ART program and can generate adequate fertilization and pregnancy rates. We have previously shown that the quality and fertilizing capacity of ZSC recovered sperm is comparable to that recovered via Percoll gradients. However, the ZSC when compared to the Percoll method was less time consuming (5 minutes of actual labor) and less tedious by eliminating the dilution and centrifugation steps of Percoll preparation, since it washes the sperm while simultaneously selecting it. The ZSC is a standardized semen preparation method and could be the method of choice in an ART program.
Comparison of characteristics of human spermatozoa selected by the multiple-tube swim-up and simple discontinuous Percoll gradient centrifugation. [2019]The multiple-tube swim-up (MT-SU) and simple, discontinuous Percoll gradient centrifugation are two recent methods for the processing of human spermatozoa for assisted reproductive technologies. The present study was undertaken to compare the effects of these two methods on various parameters of spermatozoal qualities of normospermic semen samples. Both methods were found to select spermatozoa of better percentage motility, percentage normal morphology, viability, functional integrity of plasma membrane, movement characteristics including the curvilinear velocity, linearity of movement and head beat frequency, and in vitro fertilizing capacity with comparable degree of efficacy. It is concluded that both methods are effective for the separation of spermatozoa from normospermic semen samples for use in infertility treatment.
Comparison of centrifugation- and noncentrifugation-based techniques for recovery of motile human sperm in assisted reproduction. [2019]To compare standard density gradient centrifugation sperm preparation with a novel non-centrifugation-based dual-chamber capillary dish in efficiency for motile human sperm separation, approximately 3 mL fresh ejaculate specimens was obtained from 21 men (median age = 32 years. range 26-42 years) undergoing infertility evaluation. For each specimen, half of the sample was processed with a standard 45%/90% density gradient preparation (PureSperm. Nidacon International, Gothenburg, Sweden) followed by semen analysis. The other half was incubated in the Zech glass capillary dish (Astromedtec, Salzburg, Austria) consisting of 2 concentric wells overlaid by a U-ring and coverglass. After approximately 3 h, a 1-mL sample was taken from the central chamber and analyzed. Percentage motile sperm recovery, absolute (motile) cell number, and path velocities were compared for spermatozoa obtained from both methods. Both techniques reduced overall sperm concentration while enriching specimens with more motile spermatozoa. A trend towards higher % recovery of motile spermatozoa (p = .264) was observed with the Zech device, but at a cost of fewer absolute numbers of higher velocity cells (p = .004). The Zech device, therefore, localized a very small population of motile sperm without exposure to centrifugation stress, which has been considered potentially harmful to spermatozoa. This technique could theoretically improve efficiency by reducing time required to identify motile cells in in vitro fertilization where intracytoplasmic sperm injection is planned. However, refinements in incubation interval and suspension volumes are needed before this technique can be considered comparable to the density gradient method in recovering sperm for use in intrauterine insemination.